Class Class II

Infusomat® Space Volumetric Infusion Pump Administration Sets (K243392)

K243392 2025-07-24 Traditional
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Description

Infusomat® Space Volumetric Infusion Pump Administration Sets by B.Braun Medical, Inc., an FDA 510(k) cleared general hospital device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK243392
Clearance Date2025-07-24
Clearance TypeTraditional
Product CodeFPA
Regulation Number880.5440

Categories

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Predicate lineage for K243392

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Infusomat® Space Volumetric Infusion Pump Administration Sets (K243392) cites 1 predicate device and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K142036INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP ADMINISTRATION SETSB.Braun Medical, Inc.2014

Trace the full predicate network for K243392

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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